Data / Medical devices / Denmark / R82 A/S
R82 A/S: FDA-registered device maker in GEDVED Midtjylland, Denmark, 2 510(k) clearances
R82 A/S is registered with the FDA (registration 3001657382) in GEDVED Midtjylland, Denmark. It lists 9 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 20, 2016. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3001657382
- Address
- Parallelvej 3, GEDVED Midtjylland, Denmark, DK-8751
- Owner or operator
- R82 A/S (9034750)
- Roles
- Manufacturer
- First device listed
- March 9, 2002
- Registered through
- 2026
- Brand names listed
- Addax, Caribou, Chilla, Cricket, Crocodile, Flamingo, Flamingo Curo, Flamingo High-Low and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Wheelchair | KNO | 1 | Manufacturer | accessdata.fda.gov |
| Adaptor, Hygiene | ILS | 1 | Manufacturer | accessdata.fda.gov |
| Chair, Adjustable, Mechanical | INN | 1 | Manufacturer | accessdata.fda.gov |
| Chair, With Casters | INM | 1 | Manufacturer | accessdata.fda.gov |
| Stroller, Adaptive | LBE | 1 | Manufacturer | accessdata.fda.gov |
| Table, Mechanical | INW | 1 | Manufacturer | accessdata.fda.gov |
| Table, Powered | INQ | 1 | Manufacturer | accessdata.fda.gov |
| Walker, Mechanical | ITJ | 1 | Manufacturer | accessdata.fda.gov |
| Wheelchair, Mechanical | IOR | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 20, 2016 | K151492 | Kudu | IOR | Substantially Equivalent | R82 A/S | accessdata.fda.gov |
| April 12, 2010 | K100084 | MULTI FRAME WHEELCHAIR | IOR | Substantially Equivalent | R82 A/S | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 8, 2021 | 89236 | Class II | Terminated | R82 by ETAC Push Brace for High-Low | The chrome surface of the push brace can crack during use, potentially cutting the user. | accessdata.fda.gov |
| March 6, 2020 | 85210 | Class II | Terminated | Chest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Rabbit Up, Model Numbers: 869810, 869820, 869830 | The plastic plug on the chest support for Mustang and Rabbit/Rabbit Up can come loose without use of a tool. | accessdata.fda.gov |
| March 28, 2019 | 82571 | Class II | Terminated | Wombat Living, Size 3, Item Numbers: 953121-00, 953126-00, 953131-00, 953132-00, 935-135-00, 935136-00, 953211-00, 953221-00, 953222-00, 953225-00, 953226-00, 953231-001, 953232-00, 953236-00 Product Usage: Activity chai | Firm received feedback form the market regarding breakage of the plastic joint which connects the back to the seat. | accessdata.fda.gov |
| June 30, 2017 | 81217 | Class II | Ongoing | Heron toilet and bath chair Model 880505-01 & 880505-11 | Replacement campaign on all units that have a gas spring head in aluminum. | accessdata.fda.gov |
Compare with other makers
- All makers of Accessories, Wheelchair
- All makers of Wheelchair, Mechanical
- All makers of Chair, With Casters
- All makers of Table, Powered
- All makers of Chair, Adjustable, Mechanical
- All makers of Walker, Mechanical
Updated May 20, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.